Methylphenidate in KBG syndrome
- Conditions
- KBG syndromeTherapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
- Registration Number
- CTIS2023-506202-40-01
- Lead Sponsor
- Stichting Radboud University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 15
Age 6-20 years, Molecularly confirmed diagnosis of KBG syndrome (pathogenic ANKRD11 variant or a chromosome 16q24 deletion including ANKRD11), Attention deficit or ADHD-related symptoms or a formal ADHD diagnosis, with a significant impact on daily life, Presence of a subject’s caregiver or supervisor for proxy-reports
Family history of acute cardiac death that warrants further cardiac investigation, Inability to understand or speak Dutch, Cardiovascular disease in medical history (severe hypertension, heart failure, arterial occlusive disease, potentially life-threatening arrythmias, angina pectoris, hemodynamically significant congenital heart defect, cardiomyopathy, myocardial infarction and channelopathy), Current or previous presence of hyperthyroidism, glaucoma or pheochromocytoma, Use of (psychotropic/stimulant) drugs which interact with methylphenidate, Schizophrenic or psychotic disorder in medical history, Unstable epilepsy (not controlled with medication), History of frequent drug and/or alcohol abuse, Excessive alcohol/drug use and/or intoxication with one or both during the study, Pregnant or lactating women
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method